Summary of Product Characteristics (SmPC) - Folic Acid tablets BP 0.4 mg
1 NAME OF THE MEDICINAL PRODUCT
Folic Acid 0.4 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.40 mg Folic Acid BP (anhydrous).
Product contains lactose.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Appearance: Pale yellow, circular, biconvex tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Folic acid tablets 0.4 mg are indicated for the prevention of first occurrence neural tube defects in the foetus. For use by women who are planning a pregnancy.
4.2 Posology and method of administration
Adult females: One tablet (0.4mg) daily Supplementation should begin by taking one tablet (0.4 mg) daily prior to conception and be continued for at least the first 12 weeks of pregnancy.
Administration: Oral. The tablets should be swallowed with a drink of water.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Folic acid should not be given alone in the treatment of Addisonian pernicious anaemia and other vitamin B12 deficiency states, as this may precipitate the onset of subacute combined degeneration of the spinal cord. Patients with malignant disease, unless megaloblastic anaemia due to folic acid deficiency. Should not be taken by people with folate dependant tumours.
4.4 Special warnings and precautions for use
Folic acid should not be administered for treatment of pernicious anaemia or undiagnosed megaloblastic anaemia without sufficient amounts of cyanocobalamin (vitamin B12) as folic acid alone will not prevent and may precipitate development of subacute combined degeneration of the spinal cord. Therefore a full clinical diagnosis should be made before initiating treatment.
Women with pre-existing diabetes, obesity, family history of neural tube defects, or previous pregnancy affected by neural tube defect have an increased risk of having a pregnancy affected by a neural tube defect and higher doses should be considered.
Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
Folic acid status may be affected by a number of drugs:
- Antiepileptics: Folic acid can reduce plasma concentrations of anticonvulsants, particularly phenytoin, phenobarbital and primidone and therefore patients on anti- epileptic therapy may need to have their dose adjusted at regular intervals and should be under the supervision of a physician while taking folic acid supplements
- Antibacterials: chloramphenicol and co-trimoxazole may interfere with folate metabolism
- Sulfasalazine: can reduce the absorption of folic acid
- Preparations containing folic acid or its derivatives may decrease the effectiveness of methotrexate.
Patients with hypersensitivity to folic acid have been demonstrated to have antibodies that cross react with other folic acid analogues, including methotrexate, folinic acid and aminopterin.
4.6 Fertility, pregnancy and lactation
Pregnancy
The product is indicated for use during pregnancy. In normal use, the recommended dose of 400 μg of folic acid per day is not associated with deleterious effects during pregnancy and lactation.
Breast-feeding
Folic acid is actively excreted in human breast milk. Accumulation of folate in milk takes precedence over maternal folate needs. Levels of folic acid are relatively low in colostrum but as lactation proceeds, concentrations of the vitamin rise. No adverse effects have been observed in breast fed infants whose mothers were receiving folic acid.
4.7 Effects on ability to drive and use machines
Folic Acid Tablets have no influence on the ability to drive and use machines.
4.8 Undesirable effects
| Gastrointestinal disorders Rare (≥1/10,000 to <1/1,000) | Anorexia, nausea, abdominal distension and flatulence |
| Immune system disorders | |
| Rare (≥1/10,000 to <1/1,000) | Allergic reactions, comprising erythema, rash, pruritus, urticaria, and dyspnoea. |
| Not known (cannot be estimated from the available data) | Anaphylactic reaction |
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit /risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google play or Apple App Store.
4.9 Overdose
Overdose is not normally a problem. Folic acid is stored in the liver and cerebrospinal fluid. Any excess to requirement is excreted in the urine.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Folic acid and derivatives: ATC Code BO3B B01
Folic Acid is essential in preventing megaloblastic anæmia especially if it is deficient in poor nutritional states, pregnancy or anti-epileptic patients. Folic Acid has been demonstrated to prevent recurrence of neural tube defects, as well as to prevent first occurrence neural tube defect when taken in different doses of 4mg and 0.4mg respectively.
Folic acid is a member of the vitamin B group. Folic acid is reduced in the body to tetrahydrofolate, which is a coenzyme for various metabolic processes including the synthesis of purine and pyrimidine nucleotides, and hence in the synthesis of DNA; it is also involved in some amino-acid conversions, and in the formation and utilisation of formate.
5.2 Pharmacokinetic properties
Absorption
Folic acid is absorbed mainly from the proximal part of the small intestine. The naturally occurring folate polyglutamates are largely deconjugated and reduced prior to absorption. It is the 5-methyltetrahydrofolate, which appears in the portal circulation, where it is extensively bound to plasma proteins.
Distribution
Via portal circulation. 5MTHF from naturally occurring folate is extensively plasma bound. The principle storage site of folate is in the liver; it is also actively concentrated in the CSF. Folate is distributed into the breast milk.
Elimination
There is an enterohepatic circulation for folate; about 4 to 5 micrograms is excreted in the urine daily. Administration of larger doses of folic acid leads to proportionately
more of the vitamin being excreted in the urine. Folic acid is distributed into breast milk.
Biotransformation
Therapeutically given folic acid is converted into the metabolically active form 5MTHF in the plasma and liver. There is an enterohepatic circulation for folate.
Elimination
Folate metabolites are eliminated in the urine and folate in excess of body requirements is excreted unchanged in the urine. Folic acid is removed by haemodialysis
5.3 Preclinical safety data
Folic Acid is a drug on which extensive clinical experience has been obtained Folic acid is not mutagenic. Massive doses in rats and in rabbits (100mg/kg upwards) produced precipitation of folate crystals in the neural tubules, particularly the proximal tubules and in the ascending limb of the Loop of Henle. Tubular necrosis is followed by recovery.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose PhEur
Maize Starch PhEur
Pregelatinised Starch BP
Magnesium Stearate PhEur Purified Water PhEur (Not detected)
6.2 Incompatibilities
None stated.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Store below 25°C in a dry place. Protect from light.
6.5 Nature and contents of container
Blister packs consisting of 250 µm clear PVC and 20 µm hard temper aluminium foil contained in a carton. Pack sizes: 28, 56, 84, 90, 98 and 100 tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Relonchem Limited
Cheshire House
Gorsey Lane
Widnes
WA8 0RP
8 MARKETING AUTHORISATION NUMBER(S)
PL 20395/0106
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
18/03/2009
10 DATE OF REVISION OF THE TEXT
13/08/2024